Pioneer Hi-Bred International, Inc. Petition (20-203-01p) for the 

Determination of Nonregulated Status for Insect Resistant and 

Herbicide-Tolerant DP23211 Maize

Finding of No Significant Impact

OECD Unique Identifier: DP-Ø23211-2 

October 2023

Agency: United States Department of Agriculture, Animal and Plant Health Inspection

Service, Biotechnology Regulatory Services

Agency Contact: 

Alan Pearson

USDA, APHIS 

Biotechnology Regulatory Services 

4700 River Road 

Riverdale, MD 20737 

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and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering 

USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender 

identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, 

income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights 

activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). 

Remedies and complaint filing deadlines vary by program or incident. Persons with disabilities who require 

alternative means of communication for program information (e.g., Braille, large print, audiotape, American 

Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 

(voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, 

program information may be made available in languages other than English. 

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD3027, found online at How to File a Program Discrimination Complaint and at any USDA office or write a 

letter addressed to USDA and provide in the letter all of the information requested in the form. To request a 

copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by: (1) mail: 

U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence 

Avenue, SW, Washington, D.C. 20250-9410; (2) fax: (202) 690-7442; or (3) email: 

program.intake@usda.gov. 

Mention of companies or commercial products in this report does not imply recommendation or endorsement 

by the U.S. Department of Agriculture (USDA) over others not mentioned. USDA neither guarantees nor 

warrants the standard of any product mentioned. Product names are mentioned solely to report factually on 

available data and to provide specific information. 
1

Overview

The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) 

regulations at Title 7 of the Code of Federal Regulations part 340 (7 CFR part 340) govern the movement 

(e.g., transport, environmental release) of organisms developed using genetic engineering that may pose a 

plant pest risk. APHIS recently revised 7 CFR part 340, publishing a final rule in the Federal Register on 

May 18, 2020.

1 The revisions to 7 CFR part 340 were implemented in phases: APHIS’ new Regulatory 

Status Review (RSR) process, which replaced the prior “petition” for determination of nonregulated status 

process, became effective on April 5, 2021 for corn, soybean, cotton, potato, tomato, and alfalfa. The 

RSR process became effective for all crops as of October 1, 2021. As provided for in the final rule, “Until 

RSR is available for a particular crop...APHIS will continue to receive petitions for determination of 

nonregulated status for the crop in accordance with the [legacy] regulations at 7 CFR 340.6”. Under the 

petition process, an organism developed using genetic engineering is no longer subject to the 

requirements of 7 CFR part 340 or the plant pest provisions of the Plant Protection Act (PPA; 7 U.S.C. 

7701 et seq.) if APHIS determines, through conduct of a Plant Pest Risk Assessment (PPRA), that it is 

unlikely to pose a plant pest risk (USDA-APHIS 2022a). 

In July 2020, Pioneer Hi-Bred International, Inc. (Pioneer) submitted a petition (20-203-01p) to USDAAPHIS requesting that DP23211 maize (corn),2 a plant developed using genetic engineering, and any 

progeny derived from it, no longer be regulated under 7 CFR part 340 (Pioneer 2020). Pioneer’s petition 

for a determination of nonregulated status has been evaluated in accordance with the legacy regulations at 

7 CFR 340.6, as it was received by APHIS in July, 2020, prior to full implementation of the final rule, 

discussed above.

Pioneer developed DP23211 corn for resistance to the insect pest western corn rootworm (WCR; 

Diabrotica virgifera virgifera), and the herbicide active ingredient (a.i.) glufosinate-ammonium.3 WCR

resistance is conferred using two different methods; RNA interference (RNAi), and a protein toxic to 

WCR. DP23211 corn produces a double-stranded ribonucleic acid (dsRNA), termed DvSSJ1 dsRNA, 

which interferes with production of DvSSJ1 protein via RNAi—a protein essential for gut epithelium 

function—and causes WCR death. WCR resistance is also conferred by DP23211 corn production of an 

insecticidal IPD072Aa protein that is likewise lethal to WCR when ingested.

As part of evaluation of Pioneer’s petition USDA-APHIS developed an Environmental Assessment (EA) 

to consider the potential impacts of a determination of nonregulated status for DP23211 corn on the 

1 Federal Register / Vol. 85 / No. 96 / Monday, May 18, 2020 / page 29790: USDA-APHIS, Movement of Certain Genetically 

Engineered Organisms [https://www.aphis.usda.gov/brs/fedregister/BRS_2020518.pdf] 2 Maize is the botanical term used globally for the cereal plant Zea mays. In the United States maize is commonly referred to as 

corn. Both terms are used interchangeably in this document. For consistency with the common plant name and petition APHIS 

uses the term maize, but also refers to corn in certain instances, such as in reference to food products. 3 Note that “Resistance” to herbicides is defined by the Herbicide Resistance Action Committee (HRAC) as the inherited ability 

of a plant population to survive and reproduce following repeated exposure to a dose of herbicide normally lethal to the wild 

type. “Tolerance” is distinguished from resistance and defined by HRAC as the inherent ability of a plant to survive and 

reproduce following exposure to an herbicide treatment. This implies that there was no selection or genetic manipulation to make 

the plant tolerant; it is naturally tolerant. In reference to biotechnology-derived crops, the terms “resistance” and “tolerance” are 

often used interchangeably. Throughout this EA, APHIS will use the term “resistance” and “resistant”, and “herbicide-resistant” 

(HR), when referring to biotech corn. 
2

human environment.4 The EA was prepared in compliance with the National Environmental Policy Act 

(NEPA, 42 U.S.C. § 4321 et seq.), the Council on Environmental Quality’s (CEQ) NEPA-implementing 

regulations (40 CFR parts 1500-1508), and USDA and APHIS NEPA-implementing regulations (7 CFR 

part 1b, and 7 CFR part 372).

Pursuant to 40 CFR § 1501.6 agencies are required to prepare a Finding of No Significant impact 

(FONSI) and make the FONSI available to the public if the agency determines, based on the EA, to not 

prepare an environmental impact statement (EIS) because the proposed action will not result in significant 

impacts on the human environment.

5 Because the proposed action is not similar to one for which an EIS 

is normally prepared, nor is the nature of the proposed action without precedent, a 30-day public review 

of the FONSI, as described in 40 CFR § 1501.6(2), does not apply. This document describes the rationale 

for the FONSI and decision to approve of the petition. The EA in support of this FONSI is available 

online at www.regulations.gov [Docket No. APHIS–2020–0098], the APHIS website [(USDA-APHIS 

2022b), see Petition No. 20-203-01p], and is incorporated by reference in its entirety. 

Public Involvement

On November 3rd, 2020 APHIS announced in the Federal Register that it was making Pioneer’s petition 

available for public review and comment to help identify potential environmental and interrelated 

economic issues that APHIS should consider in evaluation of the petition.6 APHIS accepted written 

comments on the petition for a period of 60 days, until midnight, January 4th, 2021. At the end of the 

comment period APHIS had received four comments on the petition. One comment was from an 

individual, which stated opposition to genetically engineered crops in general. Three comments were 

received from industry organizations, which generally supported approval of the petition. 

On April 11th, 2023 APHIS published a notice in the Federal Register that it was making a draft EA, and

draft plant pest risk assessment, available for public review and comment for a period of 30 days, ending 

midnight, May 11th, 2023. At the end of the comment period APHIS had received 3 comments on the 

draft EA. One comment submitted by an individual expressed concern about the insecticidal DvSSJ1 

dsRNA in DP23211 corn, targeting Western corn rootworm. Another comment by an individual 

expressed opposition to biotechnology-derived crops, in general. A comment from the Tennessee Farm 

Bureau Federation expressed support for the deregulation of DP23211 corn. 

APHIS provided a response to comments on the draft EA in Appendix 2 of the final EA. No issues were 

raised in public comments that suggested potentially significant environmental impacts could occur as a 

4 Human environment means comprehensively the natural and physical environment and the relationship of present and future

generations of Americans with that environment (40 CFR § 1508.1(m)). 5 40 CFR § 1501.3 – Determine the appropriate level of NEPA review: (a) In assessing the appropriate level

of NEPA review, Federal agencies should determine whether the proposed action: (1) Normally does not have significant effects 

and is categorically excluded (§ 1501.4); (2) Is not likely to have significant effects or the significance of the effects is unknown 

and is therefore appropriate for an environmental assessment (§ 1501.5); or (3) Is likely to have significant effects and is 

therefore appropriate for an environmental impact statement. (b) In considering whether the effects of the proposed action are 

significant, agencies shall analyze the potentially affected environment and degree of the effects of the action. 6 Federal Register, / Vol. 85, No. 213 / Tuesday, November 3, 2020, p. 69564. Pioneer Hi-Bred International, Inc.; Availability of 

a Petition for the Determination of Nonregulated Status for Insect Resistant and Herbicide Tolerant Maize [Docket No. APHIS–

2020–0098]. Available at https://www.federalregister.gov/documents/2020/11/03/2020-24267/pioneer-hi-bred-international-incavailability-of-a-petition-for-the-determination-of-nonregulated
3 

result of cultivation of DP23211 corn, and utilization of DP23211 corn for production of food, animal 

feed, fuel ethanol, and industrial commodities. 

APHIS considered all comments received in preparation of the draft and final EA. A full record of each 

comment received is available online at www.regulations.gov [Docket No. APHIS-2020-0098].

Alternatives Evaluated 

NEPA implementing regulations (40 C.F.R. 1500–1508) require agencies to evaluate alternative actions

that would avoid or minimize adverse impacts, or enhance the quality of the human environment, while

meeting the purpose and need for Agency action (in this case, a regulatory decision). Two alternatives 

were evaluated in the EA: (1) No Action, denial of the petition, which would result in APHIS regulation 

of DP23211 corn, and (2) Preferred Alternative, approval of the petition, which would result in a 

determination of nonregulated status for DP23211 corn. 

No Action: Deny the Petition

APHIS considered a “No Action Alternative” as required by CEQ regulations (40 CFR § 1502.14 (c)). 

For APHIS, no action in this context means no change in regulated status. Under the No Action 

Alternative APHIS would deny the petition request for nonregulated status and DP23211 corn would 

remain regulated under 7 CFR part 340. Any movement or environmental release of DP23211 corn would 

require an APHIS permit. 

Preferred Alternative: Approve the Petition for Nonregulated Status

Under this alternative APHIS would approve the petition request. DP23211 corn and progeny derived 

from it would no longer be subject to APHIS regulation under 7 CFR part 340. Permits issued by APHIS 

would no longer be required for movement or environmental release of DP23211 corn. 

Finding of No Significant Impact 

APHIS developed topics for consideration in the EA based on issues identified in public comments on 

the petition, prior EAs for biotechnology-derived corn varieties, the scientific literature on agricultural 

biotechnology, and issues identified by APHIS specific to wild and cultivated Zea and Tripsacum species. 

The following topics were identified as relevant to the scope of the impacts analysis in the EA (40 CFR § 

1501.9–Scoping): 

• Agricultural Production: Acreage and areas of corn production, agronomic practices and inputs

• Physical Environment: Soils, water resources, air quality

• Biological Resources: Soil biota, animal communities, plant communities, gene flow and 

weediness, biodiversity

• Public health and worker safety

• Food animal health and welfare

• Domestic economy and international trade
4

• Potential impacts on threatened and endangered species 

• Compliance of the Agency’s regulatory status decision with Executive Orders, and 

environmental laws and regulations to which the action is subject.

In evaluating the potential significance of impacts on the human environment APHIS considered those 

requirements outlined in sections 102(2)(C) of NEPA, 40 CFR § 1501.3–Determine the appropriate level 

of NEPA review, 40 CFR § 1502.16–Environmental consequences, and 40 CFR § 1502.24–

Environmental review and consultation requirements, and 40 CFR § 1502.15–Affected environment, 

which are summarized below. The potential impacts/effects identified and discussed in the EA include 

those that may be both beneficial and adverse; on balance the agency believes that the potential impacts 

of approval of the petition would be largely beneficial to U.S. corn production and corn-based food, feed, 

and fuel ethanol markets (40 CFR § 1508.1(g)).

1. Potential adverse environmental effects that cannot be avoided should the proposal be implemented

Commercial crop production of any type, whether a conventional, organic, or biotechnologybased cropping system always has some degree of impact on the environment, as discussed in the

EA. Potential introduction of pesticides and fertilizers to surface water, soil erosion, and loss of 

biodiversity and wildlife habitats are examples of impacts that can potentially derive from 

commercial crop production. The degree of environmental impacts can be minor or noticeably 

adverse, depending on a variety of factors that include the type and quantity of agronomic inputs 

and practices employed, geography and proximity of surface waters to crops, local biota, weather, 

prevalence and diversity of insect pests and weeds, and crop type being produced. With around 

360,000 corn farms comprising some 90 million acres of land in the United States the scale of 

potential impacts, namely in an aggregate sense, requires integration of crop production with 

sustainability and conservation practices, for biotechnology-derived, conventionally bred, and 

organic crops alike. Implementing such practices can often result in significant mitigation of 

environmental impacts, however, not all impacts can be fully attenuated and accepting some 

degree of environmental impact/change in meeting the market demand for corn-based food, feed, 

fuel, and industrial commodities is inevitable (Robertson and Swinton 2005; NRC-IM 2015).

On approval of the petition, and subsequent grower adoption of DP23211 corn, the agronomic 

practices and inputs that would be used in the cultivation of DP23211 corn, and any contribution 

of these practices and inputs to impacts on soils, water quality, or air quality, is expected to be 

similar to that of other corn crops currently cultivated. It is expected that DP23211 corn would be 

produced on lands already converted to cropland—replace other HR/IR corn crops currently 

cultivated. Hence, adoption of DP23211 corn is not expected to have any effect on wildlife

habitats or biodiversity. The EA did not identify any significant changes to agronomic practices

and inputs, nor in DP23211 corn physiology, that would have effects on plant diseases or insect 

pests, or their management (USDA-APHIS 2022a).

There are various federal, state, and private sector collaborative initiatives to support sustainable 

agricultural practices and help alleviate the collective impacts of crop production on the physical 

environment, as well as biological resources—these are summarized the EA.
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2. The relationship between short-term uses of man’s environment and the maintenance and enhancement 

of long-term productivity

Long-term agricultural productivity depends on the sustainable utilization of natural resources

over continued production cycles—namely topsoils, groundwater, beneficial insect populations

such as plant pest predators, the plants that support beneficial insects, and products such as 

fertilizers that derive from natural resources. DP23211 corn is agronomically equivalent to other 

dent corn cultivars and production utilizes the same types, and same/similar quantities of 

resources, as all other conventional and biotech dent corn varieties. There would be reductions, to 

some extent, in fossil fuel and applied insecticide use—the utilization of the natural resources 

from which fuels and insecticides are derived. As a plant incorporated protectant (PIP) based IR 

corn variety targeting Diabrotica virgifera virgifera, and reduced insecticide use, there could be a 

reduction in adverse impacts on non-target species, including beneficial predator and parasitoid

species (Bale et al. 2008; Barratt et al. 2018). The novel RNAi (DvSSJ1 dsRNA) and IPD072Aa 

MOAs could facilitate management of development of insect resistance by broadening the variety 

of PIP MOAs in crops. These aspects of DP23211 corn would be expected to be of potential 

benefit to sustaining the long-term productivity of U.S. corn cropping systems, in association with 

the efficacy of implemented IWM and IPM programs.

3. Irreversible or irretrievable commitments of resources that would be involved in the proposal should it 

be implemented

The production of corn and the food, feed, fuel, and industrial products derived from corn 

involves the irreversible and irretrievable utilization of resources. For example, corn production 

involves the irreversible consumption of nonrenewable petroleum-based products (e.g., fuels 

necessary to operate equipment, cleaning agents, pesticide additives/adjuvants). Crude oil cannot 

be replaced once utilized for energy or other purposes. Some crop production systems may utilize 

wind or solar energy sources—renewable sources. Topsoil and phosphorus are also considered 

nonrenewable. Over the long-term, continued crop production on the same site can contribute to 

wind and water erosion. Materials such as aluminum, steel, wood, and plastics would be 

consumed as part of the process of crop production. Some of the materials used are nonrenewable and could be irreversibly utilized if not recycled (plastics, metals). Crop production 

inherently entails the irretrievable conversion of natural habitat, and relocation of associated 

wildlife to other landscapes. 

DP23211 corn is physiologically and agronomically equivalent to other dent corn varieties, apart 

from the HR and IR traits. Renewable and nonrenewable resources utilized for DP23211 corn 

production would differ little from that of other dent corn varieties. Any irreversible or 

irretrievable commitment of resources in DP23211 corn production would be the same as or 

similar to that of other dent corn cropping systems. It is expected that DP23211 corn would be 

produced on lands already converted and utilized for commercial crop production. As an IR crop 

variety utilizing PIPs, reductions in fossil fuel use could occur in production of the crop, relative 

to non-IR corn varieties on which insecticides are sprayed. Fossil fuels are commonly used in the 

manufacture, transportation, and soil and foliar application of insecticides to commercial corn 

crops. 
6

4. Whether the action would violate or conflict with federal or state laws, Executive Orders, or local 

requirements governing protection of the environment and environmental justice

Based on the data reviewed in the EA, approval of the petition would not lead to circumstances 

that resulted in non-compliance with any federal or state laws, local ordinances, or Executive 

Orders providing protections for the environment, public health, underserved communities, or

minority or low income populations. The U.S. Environmental Protection Agency (EPA) regulates

the use of pesticides on DP23211 corn, as well as worker safety. Pioneer completed a food safety 

consultation with the FDA in 2022; based on the information Pioneer presented to the FDA, the 

FDA had no further questions concerning the safety of human or animal food derived from 

DP23211 corn, noting that it is Pioneer’s continuing responsibility to ensure that foods marketed 

by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory 

requirements (US-FDA 2022).

5. Possible conflicts between the proposed action and the objectives of federal, regional, state, tribal, 

and local land use plans, policies, and controls for the area concerned

As reviewed in the final, EA, there are no conflicts with approval of the petition, and subsequent 

commercial production of DP23211 corn with federal, state, tribal, or local government oversight 

of land uses and policies. Any cultivation of DP23211 corn in the United States would require 

compliance with federal, state, or local government land management authorities (e.g., local 

ordinance, zoning). Tribal entities are recognized as independent governments and agricultural 

activities on tribal lands would only be conducted if approved by the tribe. APHIS conducted 

outreach to tribal nations informing tribes of Pioneer’s petition. APHIS received one reply from 

the Ysleta del Sur Pueblo Tribe, stating that this project will not adversely affect traditional, 

religious, or culturally significant sites.

6. Energy requirements and conservation potential of various alternatives and mitigation measures 

The energy requirements involved with the full life cycle of DP23211 corn production and 

marketing would differ little from that of other commercial corn crops. USDA-NRCS provides 

guidance on energy management in crop production via practices such as integrated pest 

management, precision agriculture, irrigation water and nutrient management, and crop residue 

management (USDA-NRCS 2020). Energy conservation estimation tools are also provided to 

help growers estimate costs and saving associated with irrigation, nitrogen use, and tillage.

7. Natural or depletable resource requirements and conservation potential of various alternatives and 

mitigation measures

Natural resources relative to crop production that are depletable (non-renewable, or renew 

slowly) include petroleum-based products (e.g., diesel fuel, gasoline, plastics, lubricants), 

fertilizer phosphorus, groundwater, and soils. There are no natural resource requirements unique 

to the production and marketing of DP23211 corn. Use of natural resources in DP23211 corn 

production would be no different than that of other corn varieties. Natural resource conservation 

opportunities, such as those provided or funded by the USDA, would be available to growers of 

DP23211 corn, summarized below in item 9. 
7

8. Urban quality, historic and cultural resources, and the design of the built environment, including the 

reuse and conservation potential of various alternatives and mitigation measures

DP23211 corn would be cultivated on lands allocated or zoned for agricultural uses, which may 

occur in proximity to historic or cultural resources. This would not be expected to directly or 

indirectly result in alteration of the character or use of historic properties protected under The 

National Historic Preservation Act, nor result in any loss or destruction of cultural or historical 

resources. As discussed in the EA, there are no weediness/invasiveness characteristics associated 

with DP23211 corn that would impact historical properties. The design of the built environment

in relation to crop production activities would be resolved at the state and local levels of 

governance (e.g., city, county, and/or state authorities governing land use).

9. Means to mitigate adverse environmental impacts

There are a number of federal, state, and private sector collaborative initiatives to help farmers 

alleviate the impacts of crop production on the physical environment, as well as biological 

resources. Some of the ongoing USDA and partner programs supporting agricultural 

sustainability and natural resources conservation (e.g., National Water Quality Initiative, Natural 

Resources Conservation Programs) are discussed in the EA (USDA-APHIS 2022b). Each 

contribute in some way to environmental stewardship and long-term farm sustainability.

10. Economic and technical considerations, including the economic benefits of the proposed action

DP23211 corn could provide for effective plant pest and weed management, achieving optimal 

yields, and efficient provision of food, feed, fuel, and industrial commodities. The economic 

impacts associated with the introduction of DP23211 corn into commerce are potentially 

beneficial (USDA-APHIS 2022b). 

IR crops have proven effective in control of insect pests, thus the extent of adoption in the United 

States—IR corn comprised 84% of U.S. corn crop acreage in 2022 (USDA-ERS 2022a). From 

1996-2018, IR corn targeting corn boring pests provided a 7% increase in yield, and increased 

farm income of $81/ha ($32/acre) (Brookes and Barfoot 2018). IR corn targeting WCR, 

specifically, provided a 5% increase in yield, and increased farm income $78/ha ($31.6/acre) 

(Brookes and Barfoot 2018). At the aggregate level, the global gross farm income gains from 

using IR corn in 2018 was $4.5 billion (Brookes and Barfoot 2018). 

The average gross farm income benefit from using HR corn (after deduction of cost of 

technology) has been around $30.1/ha ($12.5/acre). During the 1996-2018 timeframe, the 

aggregate income benefit from using HR corn in the United States has been estimated to be 

around $10.8 billion (Brookes and Barfoot 2018). In 2018, the total global farm income gain from 

using HR corn was $1.66 billion with the cumulative gain over the period 1996–2018 being $17 

billion (Brookes and Barfoot 2018).

11. The degree to which the action may adversely affect endangered or threatened species protected

under the Endangered Species Act
8

As discussed in the EA, a determination of nonregulated status of DP23211 corn, and subsequent 

commercial production of this corn variety, would have no effect on listed species or species 

proposed for listing, nor would it affect designated habitat or habitat proposed for designation. 

12. The degree to which the proposed action affects public health or safety

Approval of the petition and subsequent availability of DP23211 corn to producers, and DP23211 

corn products to commercial markets, would not present any risks to public health or worker 

safety. It is unlikely that DP23211 corn, a dent corn variety (e.g., Zea mays var. indentata), would 

be directly consumed by humans. Direct consumption of corn is generally limited to sweet corn 

(Zea mays convar. saccharata var. rugosa), popcorn (Zea mays var. everta), and flint corn (Zea 

mays var. indurata) (e.g., polenta). Dent corn is produced primarily for animal feed and industrial 

uses such as fuel ethanol production, although some specialty dent corn varieties may be used for 

grits, and processed into food products such as tortilla chips, corn syrup, corn oil, etc. Only 

certain hybrid dent corn varieties with specific starch properties are used for food purposes. 

As reviewed in EA, the introduced traits, the DvSSJ1 dsRNA, and the IPD072Aa, PAT, and PMI 

proteins, would present negligible risks to human health in the event of inadvertent consumption 

of DP23211 corn grain. Pioneer completed a food safety consultation with the FDA in 2022; the 

FDA had no questions concerning the safety of food products derived from DP23211 corn (USFDA 2022).

13. Whether the affected environment includes reasonably foreseeable environmental trends and planned 

actions in the affected areas.

Approval of the petition would provide for the commercial production of DP23211 corn, subject 

to any FDA, EPA, state, or tribal requirements. As of May 2023, APHIS has issued 

determinations of nonregulated status in response to 41 petitions for biotechnology-based corn 

varieties, most of these are insect and/or herbicide resistant. APHIS maintains a publicly available 

list of petitions and determinations of nonregulated status on its website (USDA-APHIS 2022c).

As of 2022, over 90% of U.S. corn acreage is comprised of biotechnology-based varieties

(USDA-ERS 2022b).

Advances in biotechnologies are expected to refine the precision with which crop varieties will be 

developed, and lead to a greater diversity of commercial crop varieties (NAS 2016). While it is 

difficult to predict the scope of improved crop varieties that will emerge in the coming decades, 

beneficial traits likely to be utilized and adopted by growers include improved tolerance to abiotic 

stresses such as drought and temperature extremes; increased efficiency in plant physiological

processes such as photosynthesis and nitrogen use; resistance to fungal, bacterial, and viral 

diseases; and new types of herbicide resistance (NAS 2016).

For biotechnology-based plants that APHIS has determined are not subject to 7 CFR part 340, all 

of which were evaluated for potential plant pest risks, and potential environmental impacts via 

NEPA analyses (USDA-APHIS 2022c), the scientific literature indicates that the cultivation of 

the presently commercialized biotech HR and IR corn plants have not resulted in any adverse 

environmental impacts that are unique, differ from conventional corn crops and cropping systems 
9 

(e.g., (Sanvido et al. 2007; NRC 2010; NAS 2016; Brookes and Barfoot 2017)). To date, 

biotechnology-derived crops, which undergo evaluation by USDA, the EPA, and FDA under the 

Coordinated Framework (ETIPCC 2017; USDA-APHIS 2020), have been found to have no more 

or fewer adverse effects on the environment than non-biotech crops produced conventionally 

(NRC 2010; NAS 2016; Brookes and Barfoot 2020). 

NEPA Decision and Rationale 

I have evaluated the information provided in the EA, and compliance of approval or denial of the petition 

with applicable laws, regulations, and policy, as well as public comments on the petition. Based on this 

evaluation, summarized above, I have not identified any significant impacts on the human environment 

that would derive from approval of the petition. Because APHIS did not identify any plant pest risks 

associated with DP23211 corn, the regulation of DP23211 corn would be inconsistent with the plant pest 

provisions of the PPA, APHIS regulations at 7 CFR part 340, and the biotechnology regulatory policies of 

the Coordinated Framework. For these reasons APHIS will implement the Preferred Alternative, approval 

of the petition. The Preferred Alternative is not a federal action significantly affecting the quality of the 

human environment under NEPA. Accordingly, an EIS is not required and environmental review pursuant 

to NEPA and CEQ implementing regulations is concluded with this FONSI. 

Bernadette Juarez Date 

APHIS Deputy Administrator 

Biotechnology Regulatory Services 

Animal and Plant Health Inspection Service

U.S. Department of Agriculture
10 

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